New diabetes drug rongliflozin tested in patients with kidney problems
NCT ID NCT05374343
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tested a single dose of the drug rongliflozin in 32 Chinese adults with type 2 diabetes who had normal, mildly, or moderately reduced kidney function. Researchers measured how the drug moved through the body and how it affected blood sugar and urine glucose. The goal was to see if kidney function changes how the drug works, which could guide future dosing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- rongliflozin (a drug taken by mouth)
- What this could lead to
- If successful, this could help doctors understand how rongliflozin works in people with type 2 diabetes and kidney problems, potentially leading to better blood sugar control.
- What could go wrong
- This is a very early (Phase 1) study with only 32 people, so results may not apply to everyone. The drug may not work as well in those with kidney impairment, and side effects are still being studied.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
32 people
The number who actually took part.
- Started
-
May 2022
- Finished
-
Aug 2023
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Type 2 diabetes patients. * The subject is willing to take effective contraceptive measures without a pregnancy plan within 4 weeks after signing the informed consent form to taking the test drug. * When screening, 19.0 kg/m2 \< or = body mass index (BMI) \< or = 35.0 kg/m2. * No hypoglycemic drugs have been used in the 4 weeks before the baseline period, or stable doses of hypoglycemic drugs are being used. * No medications for other comorbidities or stable medication regimens within 4 weeks before the baseline period. * In the screening period, 6.5% \< or = glycosylated hemoglobin \< or =11.0%, and fasting blood glucose \< or = 13.9 mmol/L. * Glomerular filtration rate (eGFR) \> or = 90 mL/min/1.73m2 estimated according to the modified dietary trial for kidney disease (MDRD) formula (only applicable to patients with type 2 diabetes with normal renal function). * Accompanied by mild or moderate renal impairment, the eGFR calculated according to the MDRD formula meets the following criteria: mild renal impairment: 60\~89 mL/min/1.73m2, moderate renal impairment: 30\~59 mL/min/ 1.73m2 (only for patients with type 2 diabetes with impaired renal function). * Accompanied by mild or moderate renal impairment, accompanied by stable disease in the first 3 months of the baseline period (only applicable to patients with type 2 diabetes with renal impairment). Exclusion Criteria: * Known allergy to sodium-glucose cotransporter 2 (SGLT2) inhibitor drugs or related excipients. * In the 3 months before screening, those who smoked more than 5 cigarettes per day on average or who could not give up smoking from signing informed consent to leaving the group. * Have a history of alcoholism. * Ingested any food or drink containing caffeine, xanthine, alcohol, grapefruit within 48 hours before taking the test drug. * Those who donate blood or lose a lot of blood (\>400 mL) within 3 months before taking the test drug, or have a history of blood transfusion within 1 month before screening, or plan to donate blood within 1 month after the end of the trial. * Those who have taken the trial drug or such drugs within 1 month before taking the trial drug, or participated in the clinical trial of any drug or medical device within 3 months before screening. * Those who have a positive urine drug screen or have a history of drug abuse or drug use in the past 5 years. * The subject is breastfeeding or the serum pregnancy test result is positive. * Subjects had undergone surgery within 1 month before screening, or major surgery was planned during the study period. * Have severe mental illness or language barrier, unwilling or unable to fully understand and cooperate. * History or evidence of other diseases, such as history of repeated urinary tract infections, poorly controlled high blood pressure, type I diabetes, urinary incontinence, etc. * Abnormal laboratory tests, such as a) Alanine transaminase (ALT)/Aspartate aminotransferase (AST)\>2.0×UNL and/or total bilirubin\>1.5×UNL; b) hemoglobin \<100 g/L; c) hepatitis B surface antigen positive, hepatitis C antibody positive, HIV antibody positive , Syphilis antibody positive. * The researcher believes that the subject has any situation that may interfere with the interpretation of the pharmacokinetics, efficacy and safety data of this study. * Subjects considered by the researcher to be unsuitable to participate in this trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Ping Feng
Chengdu, Sichuan, 610041, China
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